Warsaw, POL
15 hours ago
Local Regulatory Affairs Head
Currently we are looking for a person for the position: Local Regulatory Affairs Head  Place of work: Warsaw  **Tasks and responsibilities:** + Processes (as allocated to the individual team members) + Provide input to Global RA, Local and ROPU RA concepts/strategies/projects + Regulatory Intelligence: Foster close relationships with relevant Authorities and other key stakeholders + Communication & impact assessment on new requirements + Maintain allocated databases + Share best practices within the OPU + Compliance + Ensure adherence to BI and international compliance rules as well as to local legislations in allocated areas of Regulatory Affairs + Constant tracking of all compliance parameters for allocated products and processes (KPls) + Marketing Support + Preparation of short version of Summary of Product Characteristics + Responsibility for RA budget planning and spending + Ensure all Non-Compliances are reported and followed up + Managing local Regulatory Affairs team consisted of two experts **About our future employee:** + University scientific degree + Knowledge of local and international regulatory affairs regulation + Relevant experience in pharmaceutical industry/CRO is an asset + Good command of English language + Organisational and communication skills + Proactive attitude + Team- and networker + Thoroughness + Strategic thinking + Ability to judge a case + Ability to lead & learn **What we offer:** In this position, we offer employment based on a contract of employment, great possibilities of development and a bonus system. **Additionally, we offer:** + Remuneration adequate to the level of experience and competence + Independence in daily activities + Company car, phone, laptop + Opportunities for improvement and professional development + Package of non-salary benefits (medical care, life insurance, Multisport card, My Benefit cafeteria)\#LI-DNI All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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